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Carpentier-Edwards Physio Tricuspid Annuloplasty Ring

FDA UDI

Class II (US FDA UDI)

by Edwards Lifesciences LLC

Identity

Trade Name
CARPENTIER-EDWARDS PHYSIO TRICUSPID ANNULOPLASTY RING FDA UDI
Generic Name
Mitral/tricuspid annuloplasty ring, open-surgery FDA UDI
Model / Reference
6200T FDA UDI

Identifiers

Catalog Number
6200T32 FDA UDI
Primary DI / UDI-DI
00690103188462 FDA UDI
510(k) Number
K103520 FDA UDI
FDA Product Code
KRH FDA UDI
GMDN Term
Mitral/tricuspid annuloplasty ring, open-surgery FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.3800 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI
MRI Safety
MR Conditional FDA UDI

Category: Mitral/tricuspid annuloplasty ring, open-surgery

Carpentier-Edwards Physio Tricuspid Annuloplasty Ring by Edwards Lifesciences LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Mitral/tricuspid annuloplasty ring, open-surgery.

Cleared under the same submission

K103520 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Edwards Lifesciences LLC

Sources (1)

  • FDA UDI 3258c814-5ea5-4a5e-a680-d174f322e528 36 fields · synced Jun 8, 2026